Opportunity Information: Apply for PAR 11 169
Apply for PAR 11 169
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAMS Multi Center Clinical Study Implementation Planning Grants (U34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273 Alcohol Research Programs 93.846 Arthritis, Musculoskeletal and Skin Diseases Research.
- This funding opportunity was created on Jul 12, 2013 and posted on Mar 18, 2011.
- Applicants must submit their applications by Mar 1, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- Eligible applicants include: County governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Public and State controlled institutions of higher education Independent school districts Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Private institutions of higher education State governments Special district governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non U.S.) components of U.S. Organizations are not allowed
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Opportunity Summary:
The NIAMS Multi Center Clinical Study Implementation Planning Grants (U34) opportunity (Funding Opportunity Number PAR 11-169) was a National Institutes of Health (NIH) discretionary funding announcement from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) aimed specifically at helping research teams get multi-center clinical interventional trials ready to launch. The core purpose of this FOA was not to fund the trial itself, but to fund the detailed planning work that must happen before a complex investigator-initiated clinical trial can responsibly and successfully begin. It used the cooperative agreement mechanism (U34), which means NIAMS staff were expected to be involved in a collaborative way during the planning period, rather than functioning as a distant funder.
This program focused on hypothesis-driven, milestone-defined clinical interventional trials that aligned with NIAMS mission priorities in arthritis, musculoskeletal diseases, and skin diseases. In practical terms, applicants were expected to propose a clear scientific question and a trial concept that could realistically be implemented across multiple sites, and then lay out specific planning milestones that would be completed during the U34 award period. NIAMS emphasized that the proposed work needed to be a high priority for the Institute, reflecting both scientific importance and relevance to NIAMS-supported disease areas.
The U34 planning grant was positioned as a preparatory step before applying for the larger cooperative agreement intended to support full trial implementation and conduct (UM1). The announcement made it clear that completing the agreed milestones under the U34 was recommended prior to submitting a UM1 application. In other words, NIAMS was encouraging investigators to use the U34 period to finish the kinds of foundational tasks that often determine whether a multi-center trial is feasible and well-controlled, such as finalizing protocol design and producing the documentation needed to move into launch and execution. The FOA also strongly encouraged prospective applicants to consult with NIAMS staff before submitting a U34 application, signaling that early communication about fit, priorities, and expectations was an important part of a competitive strategy.
Administratively, this was a cooperative agreement under the Health funding activity category. The award ceiling listed for the opportunity was $250,000, and there was no cost-sharing or matching requirement. The FOA was originally posted March 18, 2011, with an original and final closing date of March 1, 2014, and it was archived April 1, 2014. The CFDA numbers listed included 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research) and 93.273 (Alcohol Research Programs), reflecting the broader NIH cataloging structure tied to how opportunities are indexed.
Eligibility was broad across U.S.-based organizations and governmental entities. Eligible applicants included public and private institutions of higher education, nonprofits (including those with 501(c)(3) status and certain nonprofits without it), small businesses and other for-profit organizations (other than small businesses were explicitly included), and a range of government entities such as state governments, county governments, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. The eligibility section also highlighted inclusion of organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. At the same time, the FOA explicitly excluded non-domestic (non-U.S.) entities (foreign organizations) from applying, and it did not allow foreign components of U.S. organizations, keeping the work fully within allowable U.S. organizational structures.
In summary, PAR 11-169 was designed to reduce avoidable failure points in complex multi-center clinical trials by paying for rigorous up-front planning under a milestone-driven, NIAMS-involved cooperative agreement. The intent was to produce a well-developed trial package that could then compete for and transition into a UM1-supported implementation phase, with NIAMS staff engagement encouraged early to ensure scientific fit, operational feasibility, and alignment with institute priorities. For full details, the archived announcement was linked through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PAR-11-169.html (spacing in the original link text reflects formatting in the source).
FAQs: NIAMS Multi Center Clinical Study Implementation Planning Grants (U34) - PAR 11-169
What is PAR 11-169?
PAR 11-169 is an NIH funding opportunity announcement from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) for Multi Center Clinical Study Implementation Planning Grants using the U34 cooperative agreement mechanism. It was designed to support the planning work needed to prepare a multi-center clinical interventional trial for launch.
What was the main purpose of this U34 planning grant?
The main purpose was to fund detailed, up-front planning for a complex, investigator-initiated, multi-center clinical interventional trial. The FOA emphasized that it was not intended to fund the actual conduct of the clinical trial, but rather the preparatory work required to responsibly and successfully begin the trial.
Does this grant fund the clinical trial itself?
No. The FOA stated that the goal was to support planning activities to get a multi-center clinical interventional trial ready to launch, not to pay for the full implementation and conduct of the trial.
What type of funding mechanism was used?
The opportunity used a cooperative agreement mechanism (U34). This structure anticipated that NIAMS staff would be involved collaboratively during the planning period rather than acting only as a distant funder.
What does it mean that the U34 is a cooperative agreement?
Based on the FOA description, a cooperative agreement meant NIAMS staff were expected to participate in a collaborative role during the planning period, supporting and engaging with investigators as milestones and planning tasks were developed and completed.
What kinds of studies were targeted by this program?
The program focused on hypothesis-driven, milestone-defined clinical interventional trials designed for implementation across multiple sites and aligned with NIAMS mission priorities in arthritis, musculoskeletal diseases, and skin diseases.
What does "multi-center" imply in the context of this FOA?
"Multi-center" indicates the trial concept needed to be realistic to implement across multiple sites, with planning geared toward coordinating and preparing for that multi-site structure.
What did NIAMS expect applicants to include in a competitive application?
Applicants were expected to present a clear scientific question and a multi-center trial concept, then define specific planning milestones to be completed during the U34 award period. NIAMS also emphasized the need for alignment with NIAMS mission areas and institute priorities.
What are examples of planning activities this U34 was meant to support?
The FOA highlighted foundational planning tasks that often determine feasibility and trial quality, such as finalizing protocol design and producing documentation needed to move into launch and execution.
How does the U34 relate to the UM1 mechanism?
The U34 was positioned as a preparatory step prior to applying for a larger cooperative agreement intended to support full trial implementation and conduct (UM1). The FOA recommended completing the agreed U34 milestones before submitting a UM1 application.
Was completion of U34 milestones required before applying for UM1?
The FOA recommended completing the agreed milestones under the U34 prior to submitting a UM1 application, indicating NIAMS viewed milestone completion as an important readiness step for moving into the implementation phase.
Did NIAMS encourage applicants to contact program staff before applying?
Yes. The FOA strongly encouraged prospective applicants to consult with NIAMS staff before submitting a U34 application to discuss fit, priorities, and expectations.
Which NIH institute offered this opportunity?
This funding opportunity was offered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health (NIH).
What research areas were considered a fit for this FOA?
The FOA emphasized alignment with NIAMS mission priorities, specifically arthritis, musculoskeletal diseases, and skin diseases, and noted that proposed work needed to be a high priority for the Institute.
What was the award ceiling?
The award ceiling listed for the opportunity was $250,000.
Was cost sharing or matching required?
No. The FOA stated there was no cost-sharing or matching requirement.
What was the funding activity category?
The FOA was listed under the Health funding activity category.
When was the FOA posted and when did it close?
The FOA was originally posted on March 18, 2011. The original and final closing date was March 1, 2014. It was archived on April 1, 2014.
Is this opportunity still open?
No. The FOA has been archived, with a final closing date of March 1, 2014 and an archive date of April 1, 2014.
What was the Funding Opportunity Number?
The Funding Opportunity Number was PAR 11-169.
What CFDA numbers were associated with this opportunity?
The CFDA numbers listed included 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research) and 93.273 (Alcohol Research Programs), reflecting NIH cataloging and indexing for the announcement.
Who was eligible to apply?
Eligibility was broad for U.S.-based organizations and governmental entities. Eligible applicants included public and private institutions of higher education; nonprofits (including 501(c)(3) organizations and certain nonprofits without 501(c)(3) status); small businesses; and other for-profit organizations (including those other than small businesses).
Were government entities eligible to apply?
Yes. The FOA listed multiple eligible government entities, including state governments, county governments, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities.
Were specific types of institutions explicitly included as eligible?
Yes. The eligibility section highlighted inclusion of organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies.
Were foreign organizations eligible to apply?
No. The FOA explicitly excluded non-domestic (non-U.S.) entities (foreign organizations) from applying.
Could a U.S. organization include a foreign component?
No. The FOA stated it did not allow foreign components of U.S. organizations, keeping the work within allowable U.S. organizational structures.
What was NIAMS trying to achieve with this planning program?
The FOA was designed to reduce avoidable failure points in complex multi-center clinical trials by funding rigorous, milestone-driven planning with NIAMS involvement, producing a well-developed trial package ready to compete for and transition into a UM1-supported implementation phase.
Where can the archived FOA be found?
The archived announcement was linked through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PAR-11-169.html
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